Karyopharm Therapeutics Inc. (KPTI) 2026 Q1 法說會逐字稿

Good morning, everybody. My name is Kelsey, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics first-quarter 2026 financial results conference call.

各位早安。我叫 Kelsey，今天將擔任本次電話會議的接線員。此刻，我謹代表公司歡迎各位參加 Karyopharm Therapeutics 2026 年第一季財務業績電話會議。

(Operator Instructions)

(接線員指示)

Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Mr. Brendan Strong, Senior Vice President, Investor Relations. Please go ahead.

請注意，本通話依公司要求將進行錄音。現在我想把電話交給投資人關係資深副總裁 Brendan Strong 先生。請開始。

Good morning, and thank you all for joining us on today's conference call to discuss Karyopharm's first-quarter 2026 financial results and recent company progress. We issued a press release this morning detailing our financial results for the first-quarter of 2026. This release, along with a slide presentation that we will reference during our call today, are available on our website.

各位早安，感謝各位參加今天的電話會議，討論 Karyopharm 2026 年第一季財務業績以及公司近期進展。我們今天早上已發布新聞稿，詳述 2026 年第一季的財務結果。該新聞稿以及我們今天通話中將引用的簡報投影片，皆可於我們的網站取得。

For today's call, as seen on slide 2, I'm joined by Richard, Reshma, Sohanya and Lori, who will provide an update on the results for the first-quarter, highlight the importance of the results from our Phase III SENTRY trial in myelofibrosis and provide an update on our endometrial cancer program and related commercial opportunity.

在今天的電話會議中，如投影片第 2 頁所示，我與 Richard、Reshma、Sohanya 以及 Lori 一同出席；他們將就第一季業績提供更新，強調我們在骨髓纖維化（myelofibrosis）之第三期 SENTRY 試驗結果的重要性，並更新我們的子宮內膜癌計畫及其相關商業機會。

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995 as outlined on slide 3. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent Form 10-Q or 10-K on file with the SEC and in other filings we may make in the future with the SEC.

在我們開始正式發言之前，我提醒各位，我們今天所做的若干陳述，依投影片第 3 頁所述，構成《1995 年私人證券訴訟改革法》安全港條款目的下的前瞻性陳述。由於多項重要因素，實際結果可能與這些前瞻性陳述所示有重大差異，包括我們最近向美國證券交易委員會（SEC）提交之 Form 10-Q 或 10-K 中「風險因素」章節所討論者，以及我們未來可能向 SEC 提交的其他文件中所述者。

Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any later date.

任何前瞻性陳述僅代表我們截至今日的觀點。雖然我們未來可能選擇在某個時間點更新這些前瞻性陳述，但即使我們的觀點有所改變，我們亦明確聲明不負任何更新義務。因此，您不應依賴這些前瞻性陳述作為我們在任何較晚日期之觀點的代表。

I'll now turn the call over to Richard. Please turn to slide 5.

接下來我把電話交給 Richard。請翻到投影片第 5 頁。

Good morning, and thank you for joining us today. Karyopharm continues to execute through an important period for the company with recent and upcoming milestones that we believe can unlock meaningful growth opportunities and shape our next phase. Over the past several quarters, we have focused our organization around three priorities.

各位早安，感謝各位今天加入我們。Karyopharm 持續在公司一個重要階段中推進執行；近期與即將到來的里程碑，我們相信可釋放具意義的成長機會並塑造我們的下一個階段。在過去幾個季度，我們將組織聚焦於三項優先事項。

Advancing our late-stage clinical programs, maintaining our commercial foundation in multiple myeloma and managing the business with discipline as we approach significant value-creating milestones. Since our fourth-quarter call, we have made meaningful progress across our key 2026 priorities, including reporting top line results from our Phase III SENTRY trial in myelofibrosis, completing enrollment in XPORT-EC-042 in endometrial cancer and strengthening our balance sheet through the financing completed in Q1.

推進我們後期臨床計畫、維持我們在多發性骨髓瘤的商業基礎，並在接近重要的價值創造里程碑之際，以紀律管理業務。自第四季電話會議以來，我們在 2026 年關鍵優先事項上取得實質進展，包括公布骨髓纖維化第三期 SENTRY 試驗的主要結果（top line results）、完成子宮內膜癌 XPORT-EC-042 的收案，以及透過第一季完成的融資強化資產負債表。

With these milestones and data in hand, we are now focused on the next phase of execution, advancing our regulatory and scientific engagement for SENTRY, preparing for the EC-042 top line data readout and continuing to manage the business with financial discipline.

在掌握這些里程碑與數據後，我們目前聚焦於下一階段的執行：推進 SENTRY 的法規與科學層面互動、為 EC-042 主要數據讀出（top line data readout）做準備，並持續以財務紀律管理業務。

SENTRY showed a compelling and differentiated profile for selinexor in combination with ruxolitinib, including rapid, deep and sustained spleen volume responses accompanied by a promising overall survival signal and evidence of potential disease modification, including greater reductions in variant allele frequency as early as week 24.

SENTRY 顯示 selinexor 與 ruxolitinib 聯合用藥具備引人注目且具差異化的特性，包括快速、深度且持續的脾臟體積反應，並伴隨令人鼓舞的整體存活（overall survival）訊號，以及潛在疾病修飾（disease modification）的證據；其中包括最早在第 24 週即可觀察到變異等位基因頻率（variant allele frequency）的更大幅度下降。

These findings reinforce the potential of selinexor plus ruxolitinib to address an important gap in frontline myelofibrosis treatment where treatment options remain limited and the need for therapies that can improve long-term outcomes remain high. We are very encouraged by the level of interest and enthusiasm we are hearing from the myelofibrosis KOL and patient group communities following the SENTRY readout.

這些發現強化了 selinexor 加上 ruxolitinib 的潛力，可補足第一線骨髓纖維化治療中的重要缺口；在該領域治療選擇仍然有限，而能改善長期預後的療法需求依然很高。在 SENTRY 數據讀出後，我們從骨髓纖維化的關鍵意見領袖（KOL）與病友團體社群所聽到的關注度與熱忱程度，令我們深受鼓舞。

Our next major catalyst is XPORT-EC-042 in endometrial cancer, where enrollment is now complete, and we continue to expect top line data in mid-2026. This is a biomarker-driven program focused on patients with TP53 wild-type endometrial cancer, particularly those with pMMR tumors where there remains a significant unmet need and no approved personalized biomarker-driven maintenance therapy.

我們下一個主要催化劑是子宮內膜癌的 XPORT-EC-042；目前收案已完成，我們仍預期於 2026 年年中取得主要數據。這是一個以生物標記（biomarker）為導向的計畫，聚焦於 TP53 野生型（wild-type）子宮內膜癌患者，特別是 pMMR 腫瘤患者；在此族群中仍存在顯著未被滿足的需求，且尚無獲核准的個人化、以生物標記驅動的維持治療（maintenance therapy）。

Commercially, we believe we have a strong foundation to build from. Our deep relationships across community and academic accounts and capabilities in sales, marketing, market access, patient support and medical affairs can be leveraged across future potential launches. In both endometrial cancer and myelofibrosis, we see concentrated treatment landscapes and clear unmet need.

在商業面上，我們相信我們具備可持續擴展的堅實基礎。我們在社區與學術醫療機構帳戶的深厚關係，以及在銷售、行銷、市場准入、病患支持與醫藥事務方面的能力，可在未來潛在的新產品上市中加以運用。在子宮內膜癌與骨髓纖維化兩個領域，我們都看到治療版圖相對集中且未被滿足的需求明確。

Financially, we remain disciplined. We ended the quarter with increased liquidity following our financing in March, and we continue to manage spending with a clear focus on the clinical and regulatory milestones that matter most. Our current operating plan provides us with sufficient flexibility through our major near-term clinical and regulatory catalysts, including SENTRY next steps and the EC-042 top line readout, funding us into late Q3 2026.

在財務方面，我們仍維持紀律。在 3 月完成融資後，我們於本季末的流動性有所提升，並持續以明確聚焦於最重要的臨床與法規里程碑來管理支出。我們目前的營運計畫，讓我們在近期主要臨床與法規催化劑期間具備足夠彈性，包括 SENTRY 的後續步驟與 EC-042 主要數據讀出，並可支應至 2026 年第三季末。

With that context, today's call will first cover the SENTRY highlights and next steps, followed by a deeper discussion of the upcoming XPORT-EC-042 readout, our commercial readiness and our financial performance with guidance.

在此背景下，今天的電話會議將先介紹 SENTRY 的重點與後續步驟，接著更深入討論即將到來的 XPORT-EC-042 讀出、我們的商業化準備度，以及我們的財務表現與財測指引。

I'll now turn the call over to Reshma. Reshma?

接下來我把電話交給 Reshma。Reshma？

Thank you, Richard. Before we dive into myelofibrosis and endometrial cancer, I want to take a step back and ground everyone in the biology of XPO1 inhibition and why we believe this novel mechanism has the potential to meaningfully improve outcomes for patients across both diseases as outlined on slide 7.

謝謝你，Richard。在我們深入討論骨髓纖維化與子宮內膜癌之前，我想先退一步，讓大家回到 XPO1 抑制的生物學基礎，以及為何我們相信這一新穎機制有潛力如投影片第 7 頁所示，能在兩種疾病中為患者帶來具意義的療效改善。

What's particularly compelling about XPO1 inhibition is that it allows the drug to simultaneously impact multiple highly relevant oncogenic pathways. Selinexor selectively binds to XPO1, a key nuclear export protein and blocks the transport of critical regulatory proteins out of the nucleus. By doing so, selinexor drives the retention and activation of tumor suppressor proteins such as p53, FOXO, T21 and IkappaB within the nucleus where they can exert their anticancer effects.

XPO1 抑制特別引人注目之處在於，它使藥物能同時影響多條高度相關的致癌途徑。Selinexor 會選擇性結合 XPO1（一種關鍵的核輸出蛋白），並阻斷重要調控蛋白自細胞核輸出。藉由此機制，selinexor 促使 p53、FOXO、T21 與 IkappaB 等腫瘤抑制蛋白在細胞核內保留並被活化，使其得以發揮抗癌作用。

This effect is particularly notable for myelofibrosis and endometrial cancer, given that greater than 95% and 50% of these tumors, respectively, are p53 wild-type. At the same time, it reduces the activity of oncogenic signaling pathways, including NF-kappa-B, which is of relevance to myelofibrosis. Induction of cell cycle arrest independent of the p53 pathway is also critical pathway important to both endometrial cancer and myelofibrosis.

鑑於骨髓纖維化與子宮內膜癌腫瘤中，分別有超過 95% 與 50% 為 p53 野生型，這項效應對這兩種疾病尤其顯著。同時，它也會降低致癌訊號途徑的活性，包括與骨髓纖維化相關的 NF-kappa-B。此外，誘導不依賴 p53 途徑的細胞週期停滯，也是對子宮內膜癌與骨髓纖維化皆重要的關鍵路徑。

The net effect is a coordinated biological response, including decreased tumor cell proliferation, increased apoptosis and ultimately, the potential for durable disease control. We believe this multi-pathway mechanism is a key differentiator for selinexor and underpins the breadth of activity we've observed across multiple cancers, including both MF and EC.

其淨效應是一種協調一致的生物學反應，包括腫瘤細胞增殖下降、凋亡增加，並最終具備達成持久疾病控制的潛力。我們相信這種多途徑機制是 selinexor 的關鍵差異化因素，並支撐我們在多種癌症（包括 MF 與 EC）中所觀察到的廣泛活性。

With that backdrop, let's turn to myelofibrosis and why we believe the SENTRY data are so compelling as outlined on slide 9. There remains a clear opportunity to improve upon the current standard of care. While JAK inhibitors have been an important advancement and remain the only approved class, we continue to see relatively rates of spleen volume reduction, limited impact on long-term survival and minimal evidence of true disease modification. As such, there is an unmet medical need for therapies that go beyond symptom control and deliver deeper, more durable benefit and improve long-term outcomes like overall survival.

在此背景下，讓我們轉向骨髓纖維化，並說明為何我們認為如投影片第 9 頁所示，SENTRY 的數據如此引人注目。目前仍有明確機會可改善現行的照護標準。儘管 JAK 抑制劑是一項重要進展且仍是唯一獲核准的藥物類別，我們仍持續看到脾臟體積縮小的比例相對偏低、對長期存活的影響有限，以及幾乎沒有真正疾病修飾的證據。因此，臨床上仍存在未被滿足的醫療需求：需要能超越症狀控制、帶來更深且更持久效益，並改善如整體存活等長期結果的療法。

Moving to slide 10. As I presented a few weeks ago, we're very encouraged by the top line results from our Phase III SENTRy trial. The combination of selinexor plus ruxolitinib delivered rapid and clinically meaningful spleen volume reduction as early as week 12. Importantly, that benefit was sustained through week 36. The co-primary endpoint of SVR35 at week 24 was 50% for the combination compared to 28% for ruxolitinib alone, corresponding to a statistically significant p-value of less than 0.0001.

接著看第10張投影片。如同我在幾週前所呈現的，我們對第三期 SENTRY 試驗的主要結果感到非常振奮。Selinexor 與 ruxolitinib 的合併治療，最早在第12週即帶來快速且具臨床意義的脾臟體積縮小。重要的是，該效益可持續至第36週。第24週的共同主要終點 SVR35，在合併治療組為50%，相較於單用 ruxolitinib 的28%，對應的 p 值具統計顯著性，小於0.0001。

Our second co-primary endpoint was symptom improvement at week 24. While the difference in absolute TSS was not statistically significant, patients in both arms experienced important and similar improvement from baseline. What we find particularly exciting is the intriguing signal of overall survival, arguably the most important outcome for patients with myelofibrosis.

我們的第二個共同主要終點是第24週的症狀改善。雖然 TSS 絕對值的差異未達統計顯著，但兩組患者相較基線皆出現重要且相近的改善。我們尤其感到興奮的是整體存活期的耐人尋味訊號，這可說是骨髓纖維化患者最重要的結局指標。

The combination of selinexor and ruxolitinib is the first potential treatment in myelofibrosis to suggest an overall survival improvement relative to standard of care. At the time of the top line data, the overall survival hazard ratio was 0.43 with a nominal p-value of 0.0222. In addition, post-hoc analyses demonstrate that SVR35 predicts OS, consistent with published analyses in other myelofibrosis trials that have also shown the same.

Selinexor 與 ruxolitinib 的合併治療，是骨髓纖維化領域第一個可能顯示相較標準治療可改善整體存活期的潛在療法。在主要結果資料截點時，整體存活期的風險比（hazard ratio）為0.43，名目 p 值為0.0222。此外，事後（post-hoc）分析顯示 SVR35 可預測 OS，這與其他骨髓纖維化試驗已發表的分析一致，且同樣顯示此關聯。

These findings underscore the importance of achieving rapid, deep and sustained SVR35. The greater proportion of patients on the combination arm at 32% who experienced a variant allele frequency reduction of at least 20% may be indicative of an underlying effect on the disease biology, raising the potential for true disease modification. The rapidity at which we see these VAF reductions reflect the anticlonal attributes of selinexor and mirrors both the substantial improvement in SVR35 as early as week 12, and the early improvements in overall survival.

這些發現凸顯達成快速、深度且持續的 SVR35 的重要性。合併治療組有較高比例的患者（32%）其變異等位基因頻率（VAF）降低至少20%，這可能反映對疾病生物學的潛在影響，提升真正疾病修飾（disease modification）的可能性。我們觀察到這些 VAF 降低的速度，反映 selinexor 的抗克隆（anticlonal）特性，並與最早在第12週即出現的 SVR35 顯著改善，以及整體存活期的早期改善相互呼應。

Lastly, the combination demonstrated a generally manageable tolerability profile that was consistent with what we understand about each agent individually. We did not observe any new safety signals. Importantly, with the use of the lower dose of selinexor and dual antiemetics, we've seen an improved tolerability compared to the Phase I study. We believe the combination of the XPO1 inhibitor, selinexor, and ruxolitinib delivers a very compelling and differentiated product profile with the potential to improve outcomes for patients with myelofibrosis.

最後，該合併治療展現整體可管理的耐受性概況，且與我們對各單一藥物的既有認知一致。我們未觀察到任何新的安全性訊號。重要的是，透過使用較低劑量的 selinexor 以及雙重止吐藥，我們看到相較第一期研究有更佳的耐受性。我們相信 XPO1 抑制劑 selinexor 與 ruxolitinib 的合併治療，提供非常具吸引力且差異化的產品特性，有潛力改善骨髓纖維化患者的治療結果。

Turning to slide 11. We're excited that these data have been selected for a late-breaking oral presentation at ASCO, and we expect to have a manuscript published in a peer-reviewed journal in the middle of 2026. Overall, we remain very encouraged by the SENTRY results and look forward to productive discussions with the FDA.

接著看第11張投影片。我們很高興這些資料已被選為 ASCO 的最新突破（late-breaking）口頭報告，我們也預期在2026年年中於同儕審查期刊發表論文。整體而言，我們仍對 SENTRY 的結果深受鼓舞，並期待與 FDA 進行具建設性的討論。

Let's now turn to endometrial cancer and why we're so excited about selinexor's potential to address a clear and meaningful treatment gap, particularly for patients with p53 wild-type MMR proficient tumors. As highlighted on slide 13, this is a large and well-defined patient population. Approximately half of the patients are p53 wild-type and about 80% have MMR proficient tumors. Importantly, this is not a niche segment.

現在讓我們轉到子宮內膜癌，以及為何我們對 selinexor 有潛力填補明確且重要的治療缺口感到非常興奮，特別是針對 p53 野生型且 MMR 功能正常（proficient）的腫瘤患者。如第13張投影片所示，這是一個龐大且界定清楚的患者族群。約有一半患者為 p53 野生型，且約80%為 MMR 功能正常的腫瘤。重要的是，這並非小眾族群。

It represents a substantial proportion of the overall endometrial cancer patients whose unmet need remains high. Equally important, molecular classification is already embedded in the standard of care today. That means clinicians are routinely identifying these patients in practice, which we believe positions selinexor very well for real-world adoption if our Phase III data are positive and pending regulatory approval.

這代表子宮內膜癌整體患者中的相當大比例，而其未被滿足的需求仍然很高。同樣重要的是，分子分型如今已嵌入標準治療流程。這表示臨床醫師在實務上會例行性辨識出這些患者；我們相信，若第三期數據為正且待主管機關核准，這將使 selinexor 在真實世界的採用上具備非常有利的條件。

On slide 14, we believe we have an opportunity to define a personalized biomarker-driven maintenance treatment option for patients with p53 wild-type endometrial cancer. Today, patients with advanced or recurrent EC have no personalized biomarker-driven maintenance-only therapy. And although checkpoint inhibitors are approved in combination with chemotherapy followed by checkpoint inhibitor alone, patients whose tumors are both p53 wild-type and MMR proficient gained the least benefit.

在第14張投影片中，我們認為有機會為 p53 野生型子宮內膜癌患者，建立一個個人化、以生物標記驅動的維持治療選項。目前，晚期或復發性子宮內膜癌（EC）患者並沒有僅用於維持治療、且以個人化生物標記驅動的療法。此外，雖然免疫檢查點抑制劑已核准與化療併用，之後再以檢查點抑制劑單藥維持，但腫瘤同時為 p53 野生型且 MMR 功能正常的患者獲益最少。

The RUBY trial, which evaluated dostarlimab in combination with chemotherapy in advanced or recurrent EC patients showed a marginal PFS improvement of only 0.77 in patients whose tumors were NSMP or p53 wild-type MMR proficient. This highlights the profound unmet need for the subgroup that comprises approximately 50% of all endometrial cancer patients and underscores the urgency to identify p53 wild-type directed therapies. It also highlights the substantial benefit that potentially could be observed with selinexor in patients with p53 wild-type tumors and especially those whose tumors are both p53 wild-type and MMR proficient.

RUBY 試驗評估 dostarlimab 與化療併用於晚期或復發性 EC 患者；結果顯示，在腫瘤為 NSMP 或 p53 野生型且 MMR 功能正常的患者中，PFS 的改善幅度僅為0.77（風險比）。這凸顯該亞群（約占所有子宮內膜癌患者的50%）存在深刻的未滿足需求，也強調亟需辨識針對 p53 野生型的治療。同時也凸顯 selinexor 在 p53 野生型腫瘤患者、尤其是腫瘤同時為 p53 野生型且 MMR 功能正常者，可能觀察到的顯著效益。

As seen on slide 15, the top line data in the p53 wild-type subgroup of the SIENDO study showed a very strong PFS signal with a median PFS in the selinexor arm of 13.7 months versus 3.7 months for placebo, translating to a hazard ratio of 0.41.

如第15張投影片所示，SIENDO 研究在 p53 野生型亞群的主要結果顯示非常強的 PFS 訊號：selinexor 組的中位 PFS 為13.7個月，安慰劑組為3.7個月，換算為風險比0.41。

As you can see on slide 16, with long-term follow-up, the median PFS benefit for the selinexor arm extends to 28.4 months, corresponding to a hazard ratio of 0.44. And when we focus on the patients whose tumors are p53 wild-type MMR proficient, the data become even more compelling.

如第16張投影片所示，隨著長期追蹤，selinexor 組的中位 PFS 獲益延伸至28.4個月，對應風險比0.44。而當我們聚焦於腫瘤為 p53 野生型且 MMR 功能正常的患者時，數據更具說服力。

As shown on slide 17, the median PFS approaches 40 months at long-term follow-up with a PFS hazard ratio of 0.36. These results compare very favorably to the RUBY data in which the MMR proficient p53 wild-type subgroup showed a PFS hazard ratio of 0.77. Taken together, what we see is not only a strong initial signal, but a benefit that deepens and becomes more meaningful over time. That's the dynamic we're aiming to replicate in XPORT-EC-042. To demonstrate a clear PFS advantage at top line, we also anticipate that the PFS benefit may continue to strengthen as the data mature.

如第17張投影片所示，在長期追蹤下，中位 PFS 接近40個月，PFS 風險比為0.36。這些結果與 RUBY 的數據相比非常有利；在 RUBY 中，MMR 功能正常且 p53 野生型亞群的 PFS 風險比為0.77。綜合來看，我們看到的不僅是強烈的初始訊號，且其效益會隨時間加深並變得更具臨床意義。這正是我們希望在 XPORT-EC-042 中複製的動態。為了在主要結果時點展現明確的 PFS 優勢，我們也預期隨著資料成熟，PFS 的獲益可能會持續增強。

The safety profile on slide 18 is from the long-term follow-up from SIENDO. Given that the dose of selinexor was 80 milligrams in the SIENDO trial and prophylactic dual antiemetics for the first two cycles were not mandated, we have an opportunity to observe a better safety and tolerability profile in the ongoing 042 trial. Similar to the SENTRY trial, we've been very deliberate in optimizing both the dose and supportive care.

第18張投影片的安全性概況來自 SIENDO 的長期追蹤。鑑於 SIENDO 試驗中 selinexor 劑量為80毫克，且前兩個療程並未強制使用預防性的雙重止吐藥，我們有機會在進行中的 042 試驗中觀察到更佳的安全性與耐受性概況。與 SENTRY 試驗類似，我們在劑量與支持性照護的最佳化上一直非常審慎。

In the EC-042 trial, selinexor is dosed at 60 milligrams once weekly, and we've mandated dual antiemetics during the first two cycles, which is when patients are most likely to experience nausea and vomiting. There is the potential that with an improved safety profile, patients stay on treatment longer, translating to improved efficacy. Overall, we feel very good about how the program has evolved in delivering a more optimized and patient-friendly treatment approach.

在 EC-042 試驗中，selinexor 的給藥為每週一次60毫克，且我們規定在前兩個療程必須使用雙重止吐藥，因為這段期間患者最可能出現噁心與嘔吐。若安全性概況改善，患者可能能更長時間維持治療，進而轉化為更佳療效。整體而言，我們對此計畫的演進感到非常良好，因其提供了更最佳化且更以患者為中心的治療方式。

Finally, turning to slide 19. As Richard mentioned, I'm very pleased that we have successfully completed enrollment in our Phase III XPORT-EC-042 trial. We enrolled 257 patients in the intent-to-treat population, with approximately 220 patients in the modified intent-to-treat population, which is the primary analysis population for the study. As a reminder, our statistical plan is designed to be both rigorous and efficient. We will first assess progression-free survival in the mITT population. And if that analysis is statistically significant, the alpha will then pass down sequentially to the full ITT population.

最後，來到第19張投影片。如 Richard 所提到的，我非常高興我們已成功完成第三期 XPORT-EC-042 試驗的收案。我們在意向治療（ITT）族群納入257名患者，其中約220名屬於修正意向治療（mITT）族群，這也是本研究的主要分析族群。提醒一下，我們的統計計畫在設計上兼具嚴謹與效率。我們將先在 mITT 族群評估無惡化存活期（PFS）。若該分析達統計顯著，alpha 將依序下傳至完整 ITT 族群。

As we approach the prespecified number of PFS events that will trigger the primary analysis, we remain on track to report top line results in the near term. Stepping back, I'm incredibly excited about the opportunity in front of us, not only in endometrial cancer, but also in myelofibrosis. In both areas, we have the potential to establish new standards of care and deliver meaningful benefits for patients where significant unmet need remains.

隨著我們接近將觸發主要分析的預先指定PFS事件數，我們仍按計畫在短期內公布主要結果。退一步看，我對我們眼前的機會感到無比振奮，不僅是在子宮內膜癌，也包括骨髓纖維化。在這兩個領域，我們都有潛力建立新的照護標準，並在仍存在重大未被滿足需求之處，為患者帶來具意義的效益。

I will now turn the call to Sohanya.

我現在把電話交給Sohanya。

Thank you, Reshma. As shown on slide 21, we delivered strong net product revenue growth this quarter, driven primarily by favorable gross to net dynamics, which Lori will cover in more detail. Underlying demand for XPOVIO was lower compared to the first-quarter of 2025, reflecting the impact of new competitive entrants. This is not new territory for us. We've successfully navigated competitive dynamics and returned to drive demand growth.

謝謝你，Reshma。如第21張投影片所示，本季我們實現了強勁的產品淨營收成長，主要由有利的毛額到淨額（gross-to-net）動態所帶動，Lori將會更詳細說明。XPOVIO的基礎需求較2025年第一季偏低，反映新競爭者進入所帶來的影響。這對我們而言並非陌生領域。我們已成功因應競爭態勢，並重新推動需求成長。

Turning to slide 22. There are two ways that XPOVIO is positioned that we believe sets us up for future growth amidst an evolving and competitive landscape. First, our focus remains on the community setting, which represents approximately 60% of total US sales, where many community-based physicians and patients value XPOVIO as a flexible and convenient oral option in the second to fourth line.

接著看第22張投影片。我們認為，XPOVIO目前有兩種定位方式，使我們能在不斷演變且競爭激烈的環境中為未來成長做好準備。第一，我們的重點仍放在社區醫療場域，該場域約占美國總銷售的60%；許多社區醫師與患者將XPOVIO視為第二線至第四線治療中具彈性且便利的口服選項。

Second, our distinct positioning for XPOVIO as a differentiated mechanism of action in the peri T-cell engaging therapy setting allows selinexor to be used in patients prior to a CAR-T, which is an important position given anticipated future expansion of CAR-Ts and also in patients progressing on a T-cell engaging therapy. Therefore, despite an evolving competitive landscape, we remain confident in our ability to drive growth in XPOVIO net product revenue.

第二，XPOVIO在T細胞接合療法（T-cell engaging therapy）周邊治療情境中的獨特定位，作為具差異化作用機轉，使selinexor可在患者接受CAR-T之前使用；鑑於未來CAR-T預期擴張，這是一個重要位置，同時也可用於在T細胞接合療法治療後仍出現疾病進展的患者。因此，儘管競爭格局持續演變，我們仍對推動XPOVIO產品淨營收成長的能力保持信心。

Now if we turn to slide 23, if we look at our future potential launches in myelofibrosis and endometrial cancer, these are areas where there is strong overlap with community-based accounts with fewer treatment alternatives and higher unmet need than the multiple myeloma market.

現在轉到第23張投影片，若我們看骨髓纖維化與子宮內膜癌的潛在未來上市，這些領域與社區型客戶有高度重疊，治療替代選項較少，且未被滿足需求高於多發性骨髓瘤市場。

As we prepare for these potential launches, I would like to underscore the strength and value of our highly experienced teams. We have established capabilities across sales, marketing, market access and medical affairs, all of which can be utilized to educate on the relevant disease states. This allows us to prepare for launch with minimal incremental investment preapproval and only modest additional spend post launch.

在我們為這些潛在上市做準備之際，我想強調我們高度資深團隊的實力與價值。我們已在銷售、行銷、市場准入與醫藥事務方面建立能力，皆可用於相關疾病領域的教育推廣。這使我們能以最小的核准前增量投資來準備上市，並在上市後僅需適度增加支出。

Let's now discuss the potential commercial opportunity in both myelofibrosis and endometrial cancer, starting with myelofibrosis on slide 25. In myelofibrosis, the only treatment options that patients currently have are JAK inhibitors with ruxolitinib monotherapy being the standard of care for the past 15 years and only about 1/3 of patients that receive ruxolitinib achieve a spleen volume reduction of 35% or more with 2/3 of patients not adequately responding.

接下來我們討論骨髓纖維化與子宮內膜癌兩者的潛在商業機會，先從第25張投影片的骨髓纖維化開始。在骨髓纖維化方面，患者目前僅有的治療選項是JAK抑制劑；其中ruxolitinib單藥治療在過去15年一直是照護標準，但接受ruxolitinib的患者中僅約三分之一可達到脾臟體積縮小35%或以上，約三分之二的患者反應不足。

Slide 26 provides an outline of the potential market opportunity. selinexor plus ruxolitinib targets a sizable US myelofibrosis market with roughly 20,000 patients living with the disease and limited approved options beyond JAK inhibitors.

第26張投影片概述了潛在市場機會。selinexor合併ruxolitinib鎖定規模可觀的美國骨髓纖維化市場，約有20,000名患者罹患此病，且除JAK抑制劑外核准選項有限。

With around 7,000 newly diagnosed first-line patients annually, about 4,000 of whom are addressable, we see a clear path to meaningful adoption. We believe the combination of selinexor and ruxolitinib has the potential to deliver up to approximately $1 billion in US peak annual revenue. Our sales organization is well positioned for a potential launch in myelofibrosis. We have deep relationships with the key accounts where the majority of patients are treated.

每年約有7,000名新診斷的一線患者，其中約4,000名屬於可觸及族群，我們看見明確路徑可實現具意義的採用。我們相信selinexor與ruxolitinib的組合在美國的年峰值營收潛力可達約10億美元。我們的銷售組織已為骨髓纖維化的潛在上市做好良好布局。我們與治療大多數患者的關鍵客戶建立了深厚關係。

As outlined on slide 27, 70% of myelofibrosis patients are treated in the community setting and 30% are treated in academic centers. Across both settings, the majority of patients are treated in a concentrated group of accounts, which enables us to move quickly and execute a focused high-impact launch, if approved.

如第27張投影片所示，70%的骨髓纖維化患者在社區醫療場域接受治療，30%在學術中心接受治療。在兩種場域中，多數患者集中於一小群客戶機構接受治療，這使我們在若獲核准時能迅速行動並執行聚焦且高影響力的上市。

Turning now to slide 28. We're energized by the opportunity to reshape frontline myelofibrosis treatment by pairing selinexor with the current standard of care and pending approval to drive rapid uptake and potentially transform patient outcomes.

接著看第28張投影片。我們對於透過將selinexor與目前照護標準搭配、在待核准後推動快速採用，進而重塑骨髓纖維化一線治療並可能改變患者預後的機會感到振奮。

Turning to slide 30. I'd like to share how we are thinking about the commercial opportunity in endometrial cancer, which is the most common gynecologic malignancy in the United States with 17,000 newly diagnosed advanced or recurrent patients each year and incidence and mortality rates on the rise. As Reshma mentioned, we believe we have a clear opportunity to establish selinexor as the standard of care in patients whose tumors are p53 wild-type and pMMR.

接著看第30張投影片。我想分享我們如何看待子宮內膜癌的商業機會；子宮內膜癌是美國最常見的婦科惡性腫瘤，每年約有17,000名新診斷為晚期或復發的患者，且發生率與死亡率正在上升。如Reshma所提，我們相信在腫瘤為p53野生型且pMMR的患者中，我們有明確機會將selinexor建立為照護標準。

These patients comprise approximately 50% of all endometrial cancer patients. As we look at other therapies that have driven meaningful benefit in the treatment landscape, for example, the uptake of checkpoint inhibitors in dMMR endometrial cancer and PARP inhibitors in the maintenance setting in ovarian cancer. They achieved peak share within 18 to 24 months of launch.

這些患者約占所有子宮內膜癌患者的50%。當我們觀察其他在治療版圖中帶來具意義效益的療法，例如免疫檢查點抑制劑在dMMR子宮內膜癌中的採用，以及PARP抑制劑在卵巢癌維持治療情境中的採用。它們在上市後18至24個月內達到峰值市占。

Similarly, given the high unmet need for maintenance therapy in p53 wild-type patients as well as our established commercial capabilities, we would expect adoption to be rapid. On duration, our assumptions are influenced by the fact that this would be a maintenance option. While we don't equate PFS directly with duration, the strength of our PFS data from SIENDO gives us confidence that patients can remain on therapy for an extended period. Putting this together, this represents a significant opportunity within a multibillion-dollar marketplace.

同樣地，鑑於p53野生型患者對維持治療的高度未被滿足需求，以及我們既有的商業化能力，我們預期採用速度將會很快。在治療持續時間方面，我們的假設受到其作為維持治療選項的事實所影響。雖然我們不會將PFS直接等同於治療持續時間，但SIENDO的PFS數據強度讓我們有信心，患者可在治療上維持較長一段時間。綜合而言，這在一個數十億美元規模的市場中代表顯著機會。

Turning to slide 31. In summary. From a commercial perspective, if approved, Selinexor is positioned to rapidly transform treatment in p53 wild-type endometrial cancer. We're very encouraged by the opportunity ahead and confident in our commercial readiness to support successful launches.

接著看第31張投影片。總結來說。從商業角度而言，若獲核准，Selinexor有望在p53野生型子宮內膜癌中迅速改變治療方式。我們對前方機會深受鼓舞，並對我們的商業化就緒度充滿信心，可支持成功上市。

With that, I'll turn the call over to Lori starting on slide 33.

接下來，我把電話交給Lori，從第33張投影片開始。

Thank you, Sohanya, and good morning, everyone. I will focus on the key highlights from our first-quarter financial performance and how those results position us relative to our full year expectations.

謝謝你，Sohanya，各位早安。我將聚焦於我們第一季財務表現的關鍵重點，以及這些結果如何使我們相對於全年預期處於有利位置。

Starting with revenue. Total revenue for the first-quarter was $35.1 million compared to $30 million in the prior year period. US XPOVIO net product revenue was $29.2 million compared to $21.1 million last year. This increase was driven by a decrease in gross to net, which was 21.8% this quarter versus 45% in the first-quarter of 2025 that was impacted by an atypical product return adjustment. Our gross to net reflected lower realized discounts and returns this quarter. Excluding these adjustments, our underlying gross to net was approximately 26% this quarter.

先從營收開始。第一季總營收為3,510萬美元，較去年同期的3,000萬美元增加。美國XPOVIO產品淨營收為2,920萬美元，較去年的2,110萬美元增加。此增幅主要由毛額到淨額（gross-to-net）下降所帶動；本季為21.8%，而2025年第一季為45%，當時受到一次性（非典型）的產品退貨調整影響。本季我們的毛額到淨額反映較低的實現折扣與退貨。排除這些調整後，本季我們的基礎毛額到淨額約為26%。

Turning to expenses. We remain focused on disciplined execution. R&D expenses were $33.8 million and SG&A expenses were $26.7 million, both relatively consistent year-over-year. This reflects our continued focus on prioritizing investment in our highest value clinical programs while maintaining overall cost controls. Net loss was $22.4 million for the quarter compared to $23.5 million in the prior year.

接著看費用。我們仍專注於有紀律的執行。研發費用為3,380萬美元，SG&A費用為2,670萬美元，兩者與去年同期大致一致。這反映我們持續聚焦於優先投資於最高價值的臨床計畫，同時維持整體成本控管。本季淨損為2,240萬美元，去年同期為2,350萬美元。

As a reminder, net loss includes non-cash mark-to-market adjustments related to our financing structure. From an underlying operating perspective, performance improved meaningfully with a 20% reduction in loss from operations, driven by the increase in total revenue and continued expense discipline.

提醒一下，淨虧損包含與我們融資結構相關的非現金按市價評價（mark-to-market）調整。從基礎營運角度來看，在總營收增加及持續費用控管的帶動下，營運虧損減少20%，表現有顯著改善。

Turning to the balance sheet. We are managing the business with a clear focus on our clinical catalysts and ended the quarter with $91.2 million in cash, cash equivalents and restricted cash, which includes the approximately $50 million raised this quarter. Based on our current operating plan, we expect our existing liquidity to fund operations into late in the third-quarter of 2026. We remain focused on prudent capital management as we advance our pipeline and prepare for our upcoming Phase III readout in endometrial cancer.

接著談資產負債表。我們以臨床催化劑為明確重點來管理業務，本季末現金、約當現金及受限制現金合計為9,120萬美元，其中包含本季籌得的約5,000萬美元。依據我們目前的營運計畫，我們預期現有流動性可支應營運至2026年第三季末期左右。在推進產品線並為即將於子宮內膜癌的第三期試驗讀出做準備之際，我們仍專注於審慎的資本管理。

Turning to guidance. We are reaffirming our full year 2026 outlook. We continue to expect total revenue in the range of $130 million to $150 million with license and other revenue consisting entirely of royalties over the next three quarters and US XPOVIO net product revenue of $115 million to $130 million. Finally, we also continue to expect combined R&D and SG&A expenses in the range of $230 million to $245 million in 2026. Overall, we believe our first-quarter performance and operating discipline position us well to deliver against our full year expectations in 2026.

接著談財測指引。我們重申2026年全年展望不變。我們仍預期總營收介於1.30億至1.50億美元之間，且未來三個季度的授權及其他收入將全部由權利金構成；美國XPOVIO淨產品收入預期為1.15億至1.30億美元。最後，我們也仍預期2026年研發（R&D）與銷售、一般及行政（SG&A）費用合計介於2.30億至2.45億美元。整體而言，我們相信第一季的表現與營運紀律，使我們具備良好條件在2026年達成全年預期。

With that, I'll turn the call back over to Richard.

接下來，我把電話交回給Richard。

Thank you, Reshma, Sohanya and Lori. As we have discussed today, Karyopharm has made meaningful progress against the priorities we laid out entering 2026. Across both myelofibrosis and endometrial cancer, we believe the story is consistent. Selinexor has a differentiated mechanism of action.

謝謝Reshma、Sohanya與Lori。如同我們今天所討論的，Karyopharm在進入2026年時所設定的優先事項上已取得實質進展。在骨髓纖維化與子宮內膜癌兩個領域，我們認為整體論述一致。Selinexor具備差異化的作用機轉。

The clinical programs have been refined based on experience and the commercial opportunities are meaningful. We have also worked hard to optimize how selinexor is used, including dose selection and proactive supportive care with the goal of delivering the right balance of efficacy, tolerability and real-world usability.

臨床計畫已根據經驗加以精煉，且商業機會具相當規模。我們也努力優化selinexor的使用方式，包括劑量選擇與主動的支持性照護，目標是在療效、耐受性與真實世界可用性之間取得適當平衡。

Looking ahead, our focus is clear. We are advancing the next steps for SENTRY, including FDA engagement, presentation of the data at ASCO, publication planning and potential Compendia inclusion. In endometrial cancer, we are preparing for the XPORT-EC-042 top line readout in mid-2026, which we believe represents a major potential value-creating catalyst for Karyopharm.

展望未來，我們的重點很明確。我們正推進SENTRY的下一步工作，包括與FDA互動、在ASCO發表數據、規劃論文發表，以及潛在的Compendia收錄。在子宮內膜癌方面，我們正為2026年年中XPORT-EC-042的主要結果（top line）讀出做準備；我們相信這將是Karyopharm一項可能創造重大價值的關鍵催化劑。

Across the business, we will maintain operational and financial discipline as we execute while continuing to evaluate opportunities to strengthen our financial position and extend our runway. We have an important few months ahead, and we are focused on executing with urgency, discipline and a clear commitment to bring meaningful new treatment options to patients in two areas of high unmet need.

在整體業務上，我們將在執行過程中維持營運與財務紀律，同時持續評估強化財務狀況並延長資金可支撐期間（runway）的機會。未來幾個月非常關鍵，我們將以緊迫感、紀律，以及為兩個高度未被滿足需求領域的病患帶來具意義的新治療選項之明確承諾，專注於落實執行。

We'll now open the call for questions. Operator?

現在我們開放提問。接線員？

(Operator Instructions)

(接線員指示)

Brian Abrahams, RBC Capital Markets.

RBC Capital Markets的Brian Abrahams。

Congrats on all the progress. So maybe just on the MF study. I guess I'm wondering, have you done any additional work since the top line presentation to look into some of the deaths that occurred for patients on the placebo rux arm relative to the seli plus rux arm, anything standing out that wasn't apparent at all initially? And then anything -- like, I guess, what should we be expecting beyond these initial top line data you reported at ASCO?

恭喜取得各項進展。我想先問一下MF研究。我在想，自從你們發表主要結果（top line）之後，是否又做了任何額外分析，去檢視安慰劑rux組相較於seli加rux組所發生的一些死亡事件？有沒有任何一開始完全看不出來、但後來特別突出的地方？另外，除了你們在ASCO報告的這些初步主要結果數據之外，我們還應該期待看到哪些內容？

Yes. Thanks, Brian. I think overall, again, we'll have a totality of our results as we shared at ASCO, but I'll turn to Reshma to expand on that.

是的。謝謝你，Brian。我想整體而言，我們會如同在ASCO所分享的，提供我們結果的完整面貌；不過我先請Reshma補充說明。

Yes. Thanks, Brian, for the question. So absolutely, we're looking at the deaths that occurred, specifically the 23 deaths that were reported at the time of the top line. We haven't provided greater granularity in terms of the types of deaths or the deaths across the two arms. I mean with that said, when I look at them, they're very consistent with what you would expect, right, not only in MF, but other oncology trials, right?

是的。謝謝你，Brian的提問。我們確實正在檢視所發生的死亡事件，特別是截至主要結果（top line）時所通報的23例死亡。我們尚未提供更細的資訊，例如死亡類型或兩組之間的死亡分布。不過話說回來，當我檢視這些事件時，它們與你所預期的情況非常一致，對吧？不僅是在MF，在其他腫瘤試驗也是如此。

So we're going to see a lot of deaths due to progression of disease, adverse events, et cetera. So nothing inconsistent with what you would expect and more to come, right? As we continue to evaluate these data, we'll certainly look at opportunities in which we can present it at upcoming medical congresses.

因此我們會看到許多死亡是由疾病進展、不良事件等原因所致。所以沒有任何與預期不一致之處，後續也會有更多資訊，對吧？隨著我們持續評估這些數據，我們也會尋找機會在接下來的醫學會議上進行發表。

Ted Tenthoff, Piper Sandler.

Piper Sandler的Ted Tenthoff。

Great. Thank you very much, and thanks for all the updates. Really an exciting time for Karyopharm and you guys just keep on fighting. So I appreciate that. I'm looking forward to the endometrial cancer data coming up. My question is on myelofibrosis and looking forward to the presentation at ASCO. Can you give us a little bit more information about the potential timing or sort of preparation that you're doing for the meeting with the FDA? And when could we find out sort of where their head is on a potential sNDA?

很好。非常感謝，也謝謝你們提供所有更新。對Karyopharm來說真的是令人振奮的時刻，而你們也一直持續努力奮戰。所以我很感謝。我也很期待接下來的子宮內膜癌數據。我的問題是關於骨髓纖維化，以及即將在ASCO的發表。你們能否多分享一些與FDA會議的可能時程，或你們為該會議所做的準備？我們何時可能得知他們對潛在sNDA的看法大概是什麼？

Yes. Again, I think overall, Ted, as we've shared, we're very pleased with the results and we feel the SENTRY data is very compelling and meaningful for MF patients. And I'll turn to Reshma again to kind of expand on our planned engagement with the agency.

是的。Ted，整體而言，如同我們所分享的，我們對結果非常滿意，也認為SENTRY數據對MF病患而言非常有說服力且具意義。我再請Reshma進一步說明我們與主管機關互動的規劃。

Yes, absolutely. And thank you, Ted, for the question. I just want to reiterate what Richard said. I think we're very compelled by the profile that we saw at the time of the top line results. It's not just about the spleen, right? We know that other Phase III trials have shown these spleen reductions.

好的，當然。也謝謝你，Ted的提問。我想再次強調Richard所說的。我們在主要結果（top line）時看到的整體特徵（profile）讓我們非常受到鼓舞。這不只是脾臟的問題，對吧？我們知道其他第三期試驗也顯示了這些脾臟縮小的結果。

I think what is so compelling is that it's occurring in conjunction with this very promising overall survival signal, again, as early as the data cutoff. And then it's reflected by this rapid VAF reduction, which again is a potential signal of disease modification. And we believe this is happening because of the unique aspects of XPO1 that are specifically targeting the clone, causing this anticlonal activity and again, reflected in the clinical endpoints of SVR, OS and then, of course, this disease modification as well.

我認為最具說服力的是，這些結果是與非常有前景的整體存活（OS）訊號同時出現的，即使在資料截點（data cutoff）這麼早的時間點也是如此。此外，還反映在VAF的快速下降上，而這同樣可能是疾病修飾（disease modification）的訊號。我們相信之所以會發生這些，是因為XPO1的獨特特性可特異性地針對克隆（clone），產生抗克隆活性；並再次反映在SVR、OS等臨床終點上，當然也包括這種疾病修飾的表現。

We look forward to engaging with the FDA. They've been strong partners with us from the very beginning of the SENTRY trial, and we hope to elaborate on our next steps over the course of the next couple of quarters?

我們期待與FDA互動。他們從SENTRY試驗一開始就一直是我們很強的合作夥伴，我們希望在接下來幾個季度的過程中，能更進一步說明我們的下一步計畫？

Great. Excellent. Looking forward to the presentation at ASCO.

很好。非常棒。期待在ASCO的發表。

Colleen Kusy, Baird.

Baird的Colleen Kusy。

It's Nick on for Colleen. Congrats on the progress. Just for myelofibrosis, could you discuss the gating factors for potential compendia inclusion for selinexor? And is seli is included on guidelines in the future, could you discuss how you view this opportunity versus an approval? And I just had a quick follow-up after that as well.

我是Nick，代Colleen發言。恭喜取得進展。就骨髓纖維化而言，你們能否談談selinexor可能被Compendia收錄的關鍵門檻因素（gating factors）？如果未來seli被納入治療指引，你們能否談談相較於取得核准（approval），你們如何看待這個機會？另外我之後還有一個簡短的追問。

Sure. I'll take the first part of the question, and thank you, Nick, for this important question around compendia. So we know that NCCN and other compendia, they are independent bodies. With that said, from our understanding, they're constantly looking at the literature, whether it's published literature, presented data, whether new treatments should be incorporated as part of their guidelines. And we do expect that they will be well aware of the data that we present at ASCO in the next couple of weeks.

當然。我先回答問題的第一部分，也謝謝你，Nick，提出這個關於彙編（compendia）的重要問題。我們知道 NCCN 以及其他彙編機構都是獨立的單位。話雖如此，依我們的理解，他們會持續檢視文獻，不論是已發表的文獻、已呈現的數據，以及是否應將新療法納入其指引的一部分。我們也預期他們會非常清楚我們在接下來幾週於 ASCO 所呈現的數據。

And then any publication that we do anticipate should be published in the middle of the year. So we anticipate because, again, of the importance of these data that they will be convening either ad hoc or one of their scheduled meetings. And then hopefully, fingers cross, they agree the data are compelling and will be incorporated into the guidelines. I'll let Richard take the second part of your question.

另外，我們預期任何我們所期待的論文發表會在年中左右刊出。因此我們預期，基於這些數據的重要性，他們將會召開臨時會議或在其既定的例會中討論。接著希望（但願如此），他們同意這些數據具說服力，並會被納入指引。我讓 Richard 來回答你問題的第二部分。

Yes. Nick, on the second part, and I think as you know, in myelofibrosis, they are only using one class of therapies. And again, ruxolitinib being approved over 15 years ago and really a high unmet need for these patients. As Reshma has touched on, it's very typical in these areas with new data to work to get that guideline listing pretty rapidly.

是的。Nick，關於第二部分，我想你也知道，在骨髓纖維化方面，他們目前只使用一個類別的治療。而且 ruxolitinib 在 15 年前就已獲核准，對這些病人而言確實仍有很高的未被滿足醫療需求。如 Reshma 所提到的，在這些領域一旦有新數據出來，通常會努力相當快速地取得指引收錄。

And if you look at analogs over the years, rituximab, bevacizumab, gemcitabine, et cetera, and they generated meaningful revenue based on physicians deciding to prescribe based on NCCN guidelines. So given the strong unmet need, I think you typically see -- if you only achieve NCCN listing without a label, products can achieve approximately about 50% of what peak may be if they had a label.

如果你回顧多年來的類似案例，例如 rituximab、bevacizumab、gemcitabine 等等，醫師會依 NCCN 指引決定開立處方，因而帶來可觀的營收。因此在強烈未被滿足需求的情況下，我認為通常會看到——即使只有取得 NCCN 收錄、但尚未有適應症標籤（label），產品也大約可以達到若有標籤時峰值銷售的約 50%。

So obviously, this isn't an area that we would actively promote to, but it's an area where physicians can choose to use the medicine to make sure they're fulfilling the best interest of the patients.

所以很明顯，這不是我們會主動推廣的領域，但這是一個醫師可以選擇使用該藥物、以確保符合病人最佳利益的領域。

Great. And then just on the follow-up for the endometrial for -- with 257 patients enrolled in the ITT, that was just a bit under the 276 number originally you said. Does that still provide sufficient powering to show statistics in the broader ITT population?

了解。另外就子宮內膜癌的追問——ITT 族群納入 257 位病人，略低於你先前提到原本的 276 人。這樣在更廣泛的 ITT 族群中，仍然有足夠的統計檢定力（power）來顯示統計學差異嗎？

Yes, yes. No, I really appreciate the question, Nick. So when we originally incorporated this new mITT population, again, that mITT population, by and large, consists of these patients who are going to be p53 wild-type and pMMR. Yes, you can anticipate a small subgroup of patients whose tumors are going to be dMMR and they're also medically ineligible to receive a checkpoint inhibitor.

是的，是的。Nick，我非常感謝這個問題。當我們最初納入這個新的 mITT 族群時，再次說明，mITT 族群大致上由 p53 野生型（wild-type）且 pMMR 的病人所組成。是的，你也可以預期會有一小群病人，其腫瘤為 dMMR，且同時在醫學上不適合接受免疫檢查點抑制劑。

But by and large, just assume this is going to be your p53 wild-type MMR proficient subgroup. When we originally incorporated that mITT, we assumed just based upon a proportion that, that 220 that we were targeting for that important mITT would likely equate to approximately 276 patients in that ITT.

但整體而言，你可以把它視為 p53 野生型、MMR 功能正常（proficient）的亞族群。當初我們納入 mITT 時，僅根據比例推估，我們鎖定的那個重要 mITT 族群 220 人，可能大約會對應到 ITT 族群約 276 人。

What we found though is that the proportion was a little bit different. We are still very much targeting the 220 for the mITT. That's the key population for the FDA. And based upon the distribution, we landed up with 257 patients for the ITT. Because the benefit of selinexor is driven by the P53 status and not the MMR status, yes, we are very well powered to show both meaningful benefit in the mITT as well as ITT populations.

不過我們發現實際比例有些不同。我們仍然非常明確地以 mITT 的 220 人為目標。那是 FDA 所關注的關鍵族群。而依照分布結果，ITT 族群最後是 257 人。由於 selinexor 的效益是由 P53 狀態而非 MMR 狀態所驅動，因此是的，我們在 mITT 以及 ITT 族群中，都有非常充足的檢定力來顯示具意義的效益。

Ioannis, Karyopharm.

Ioannis，Karyopharm。

I don't think Ioannis is at Karyopharm, but Ioannis, thank you for the question.

我不認為 Ioannis 在 Karyopharm，不過 Ioannis，謝謝你的提問。

It's aspirational. No, great to hear the continued operational execution here. Yes, I guess just two quick ones. Now that, that enrollment has completed here for the trial, just looking back at the SIENDO results for endometrial, obviously, the outcomes really improved with additional follow-up.

這是個願景。不，聽到這裡持續的營運執行力很棒。是的，我想就兩個簡短問題。既然這項試驗的收案已完成，回頭看 SIENDO 在子宮內膜癌的結果，顯然隨著額外追蹤，結局確實有所改善。

And so curious if you can at least kind of directionally guide us in terms of thoughts on where median follow-up would fall here for this trial? Is it going to be kind of closer to what we saw for SIENDO top line or maybe closer to the 30-plus month follow-up for the longer-term data cut?

因此想請教你是否至少能在方向性上引導我們：這項試驗的中位追蹤時間大概會落在哪裡？會比較接近 SIENDO 的頂線（top line）結果，還是比較接近 30 個月以上追蹤的長期數據截點（data cut）？

Yes. I appreciate the question, Ioannis. So we anticipate that it's probably going to be in between the two. So we had a top line results, which showed a median PFS specifically in that p53 wild-type subgroup of about 13.7 months and the placebo arm was 3.1 months. We then performed a subsequent cut that demonstrated the median PFS had increased to approximately 22 months. And then, of course, the most recent data, that long-term follow-up increased again to the median PFS of about 28 months.

是的。Ioannis，我感謝這個問題。我們預期大概會介於兩者之間。我們曾有一個頂線結果，在 p53 野生型亞族群中顯示中位 PFS 約 13.7 個月，而安慰劑組為 3.1 個月。之後我們做了下一次截點，顯示中位 PFS 提升至約 22 個月。當然，最新的數據——長期追蹤——又再提升到中位 PFS 約 28 個月。

So over those three cuts, we anticipate EC-042 to likely land in between the top line and the second cut. Now we'll see ultimately when we cut the data, it's going to be driven by when the events occur, right? But that is my anticipation going into the top line results of EC-042.

因此在這三次截點之間，我們預期 EC-042 很可能會落在頂線與第二次截點之間。當然最終要看我們何時截數據，這會取決於事件何時發生，對吧？但這是我對 EC-042 頂線結果的預期。

Got it. Okay. Very helpful. And then a quick follow-up on myelofibrosis. I guess with SENTRY-2, I think, slated to also put out data later this year, how does that kind of integrate with the effort here to get a publication out and potentially be included in compendia listing?

了解。好的。非常有幫助。另外一個關於骨髓纖維化的快速追問。我想 SENTRY-2 也預計在今年稍晚公布數據，這會如何與我們推動論文發表、以及可能被納入彙編收錄的努力相互整合？

Yes. Really exciting trial. I love this trial, right, because it really demonstrates or hopefully will demonstrate monotherapy activity of selinexor in a frontline population. I do want to reiterate, it's not exactly the same population of SENTRY-2, largely because we do allow patients with platelet counts as low as 50,000 to be enrolled. So slightly different. But again, it allows us to better understand monotherapy activity of selinexor because investigators have that opportunity to add a JAK inhibitor as early as week 12, we also get some really important combination data.

是的。這是一項非常令人振奮的試驗。我很喜歡這個試驗，對吧，因為它真正展示——或希望能展示——selinexor 在第一線族群中的單藥活性。我也想再次強調，它與 SENTRY-2 的族群並不完全相同，主要是因為我們允許血小板計數低至 50,000 的病人入組。所以會有些差異。但同樣地，這讓我們能更好地理解 selinexor 的單藥活性；此外，由於研究者最早可在第 12 週加入 JAK 抑制劑，我們也能取得一些非常重要的合併治療數據。

My hope is with this trial is that we can significantly change the landscape in MS, right? JAK inhibitors have always been thought to be the backbone. My hope is that we change and -- we now change the paradigm to XPO1 inhibitors as that backbone. Important data, I think it's going to be relevant for the patient community as well as the physician community.

我對這項試驗的期待是，我們能顯著改變 MF 的治療版圖，對吧？JAK 抑制劑一直被視為治療骨幹。我希望我們能改變——並且現在把治療典範改為以 XPO1 抑制劑作為骨幹。我認為這些重要數據對病友社群以及醫師社群都會很有關聯。

We look forward to presenting the data in the second half of 2026. And then absolutely, if the guideline committee choose to adopt and incorporate that as part of the NCCN, obviously, that's up to them. But potentially, and again, pending the data, it could be a meaningful opportunity for this patient population.

我們期待在 2026 年下半年發表這些數據。然後當然，如果指引委員會選擇採納並將其納入 NCCN，那顯然取決於他們。但這可能——同樣地，仍需視數據而定——會是這個病人族群的一個具意義的機會。

Maurice Raycroft, Jefferies.

Maurice Raycroft，Jefferies。

Congrats on progress. Just wondering, when you meet with FDA on SENTRY, do you plan to share a more mature OS cut or other specific analyses? And who are you going to bring with you to the meeting? And is there more an ex-US interaction strategy that you can share? Do you plan to meet with FDA first? Or do you want to align interactions with FDA and EMA?

恭喜進展順利。想請教一下，當你們就 SENTRY 與 FDA 會面時，是否計畫分享更成熟的 OS（總生存期）資料截點或其他特定分析？以及你們打算帶哪些人一起參加會議？另外，是否能分享更多美國以外（ex-US）的互動策略？你們計畫先與 FDA 會面嗎？或是希望讓與 FDA 與 EMA 的互動步調一致？

Yes. Thanks, Maurice, for the question. Give me a chance to present the data at ASCO first. I don't want to get ahead of ourselves. I think there's going to be a lot of really important data that Dr. Mascarenhas is going to present on behalf of all the investigators of SENTRY. And keep in mind, right, just as we reported a few weeks ago, even the SVR data, right, sort of like not only shows week 24 data, but you also got some initial glimpses at week 36 as well.

是的。謝謝你，Maurice，提出這個問題。先讓我有機會在 ASCO 上先發表資料。我不想操之過急。我認為 Mascarenhas 醫師將代表 SENTRY 的所有研究者，發表許多非常重要的資料。另外請記得，正如我們幾週前所報告的，即便是 SVR 資料，不僅呈現第 24 週的數據，也讓大家初步看到第 36 週的一些端倪。

So we do have a little bit longer follow-up as part of SVR as part of those top line results. We haven't commented on any future data cuts, right? But I will say that the study was designed to follow for long-term outcomes, especially for overall survival.

因此，作為這些主要結果的一部分，我們在 SVR 方面確實有稍長一些的追蹤期。我們尚未就任何未來的資料截點發表評論。但我可以說，該研究的設計是為了追蹤長期結局，特別是總生存期。

So patients and physicians remain blinded to the arm to which they were randomized. They continue on treatment. They continue again on the arm to which they were assigned, and will continue to follow up for overall survival. We haven't guided on when those subsequent steps or presentations will occur, but that's an opportunity based upon the trial design. In terms of the FDA 2, right, so as I mentioned earlier, we look forward to providing updates over the course of the next two quarters. At this point, we're not providing any granular details around any of our conversations either with the FDA or the broader rest of world regulatory agencies.

因此，病人與醫師仍然不知道其被隨機分派到哪一組（維持盲態）。他們持續接受治療。他們會繼續在被分派的治療組別上治療，並將持續追蹤總生存期。我們尚未指引後續步驟或發表會在何時進行，但依照試驗設計，這是一個機會。至於 FDA 方面，如我先前提到的，我們期待在接下來兩個季度的過程中提供更新。目前我們不會就與 FDA 或全球其他監管機構的任何對話提供更細部的資訊。

And overall -- and our team overall, Maurice, is working well with our partners and globally. And as Reshma touched to here in the US in terms of preparing for an sNDA and preparing and working with the regulatory agencies around the world to really advance this rapidly given the high area of unmet need for these patients.

整體而言——我們的團隊在全球範圍內與合作夥伴合作良好，Maurice。正如 Reshma 提到的，在美國這邊，我們正為提交 sNDA 做準備，並與全球監管機構合作，鑑於這些病人高度未被滿足的醫療需求，力求快速推進。

Got it. That's helpful. And maybe a quick follow-up. For EHA, we're seeing the SENTRY-2 placeholder abstract there. But the time -- the guidance for data second half, I guess, will EHA, is that still -- is the data going to be at EHA? Or can you clarify on that point?

了解。這很有幫助。我再快速追問一下。在 EHA 上，我們看到有 SENTRY-2 的佔位摘要（placeholder abstract）。但你們對資料在下半年釋出的指引——我想問，EHA 仍會有資料嗎？或你能釐清一下這點？

Yes. So that is a trial in progress. So (technical difficulty) going to be at EHA. So that abstract, yes, that's just going to be a trial in progress. And yes, we anticipate data from that trial again in the second half of this year.

是的。那是一個進行中的試驗（trial in progress）。所以（技術問題）會在 EHA。所以那個摘要，是的，只會是進行中的試驗摘要。而且是的，我們預期該試驗的資料仍會在今年下半年公布。

Jonathan Chang, Leerink Partners.

Jonathan Chang，Leerink Partners。

First, can you remind me what dose is used in the 042 study and how that compares to the SIENDO study? And what gives you confidence in the 042 study dose? And as a follow-up to that, can you remind me what the safety profile in SIENDO look like? And what gives you confidence that patients can stay on selinexor in the maintenance setting for an extended period of time?

首先，你能提醒我 042 研究使用的劑量是多少，以及與 SIENDO 研究相比如何嗎？你們對 042 研究的劑量有何信心來源？另外作為追問，你能提醒我 SIENDO 的安全性概況是什麼樣子嗎？以及你們為何有信心病人在維持治療（maintenance）情境下能長期使用 selinexor？

Yes. I really appreciate the question, Jonathan. So in SIENDO, we had a dose of 80 milligrams of selinexor. So these patients took 80 milligrams once weekly, dual antiemetics was not consistently used in that protocol. The reason I mentioned both of those is because both of those differentiate with EC-042. So in EC-042, the ongoing Phase III trial, we optimized the dose. The dose is going to be the same as SENTRY in that it's now 60 milligrams of selinexor again, dosed weekly.

是的。Jonathan，我非常感謝這個問題。在 SIENDO 中，我們使用的 selinexor 劑量是 80 毫克。因此這些病人每週一次服用 80 毫克，而該方案並未一致性地使用雙重止吐藥（dual antiemetics）。我之所以同時提到這兩點，是因為這兩點都與 EC-042 有所不同。因此在 EC-042 這項正在進行的第三期試驗中，我們優化了劑量。該劑量將與 SENTRY 相同，也就是 selinexor 60 毫克，同樣為每週給藥一次。

And in the EC-042, we also require the incorporation of dual antiemetics prior to each dose for the first two cycles. And we did that because we know nausea and vomiting are known side effects of selinexor because of the kinetics, i.e., the onset usually occurs in the first two cycles. We mandated again just for those first 8 weeks. And then, of course, it's optional thereafter.

而在 EC-042 中，我們也要求在前兩個療程（cycles）中，每次給藥前都要合併使用雙重止吐藥。我們這麼做是因為我們知道噁心與嘔吐是 selinexor 已知的不良反應，且由於其動力學特性，也就是通常在前兩個療程就會出現。我們再次強制要求僅限於前 8 週。之後當然就改為可選。

How did we pick the dose? We really looked at a comprehensive data set. So again, we know in SIENDO that the median dose was 60 milligrams. The majority of the dose reductions occurred very early, largely because of the nausea, vomiting and hematologic toxicity. We also looked at comprehensive clin pharm data. And this is really where the AUCs when we look at 80 milligrams, AUCs achieved with 80 milligrams. At 60 milligrams, there's a lot of overlap in terms of the progression-free survival that was observed across those two data points.

我們如何選擇這個劑量？我們確實檢視了一套全面性的資料集。因此再次強調，在 SIENDO 中，中位數劑量是 60 毫克。大多數的劑量下調發生得非常早，主要是因為噁心、嘔吐以及血液學毒性。我們也檢視了全面的臨床藥理（clin pharm）資料。這裡的重點在於，當我們看 80 毫克時所達到的 AUC。在 60 毫克時，就無進展存活期（PFS）而言，這兩個劑量點所觀察到的結果有很大的重疊。

So yes, a lot of confidence that, that 60 milligrams should be able to improve the safety profile of selinexor. This improvement in the safety profile is going to enable patients to stay on longer and hopefully drive what could be even potentially better efficacy than what we observed as part of SIENDO. One other thing that I will mention is that we know that the 60 milligrams does improve the safety and tolerability profile.

所以是的，我們非常有信心 60 毫克應能改善 selinexor 的安全性概況。安全性概況的改善將使病人能夠用藥更久，並希望帶來甚至可能比 SIENDO 所觀察到的更佳療效。我還要補充一點：我們知道 60 毫克確實能改善安全性與耐受性概況。

I say that because of our SENTRY data, right? So SENTRY again, incorporated 60 milligrams in combination with ruxolitinib from that data set, very pleased to see reductions both in the rates as well as grades, especially of these GI toxicities of nausea and vomiting that have been well observed with selinexor.

我之所以這麼說，是因為我們的 SENTRY 資料，對吧？SENTRY 的資料集中，將 60 毫克與 ruxolitinib 併用；我們很高興看到噁心與嘔吐等腸胃道（GI）毒性——這些在 selinexor 上已被充分觀察到——其發生率與嚴重程度分級（grades）都有所下降。

(Operator Instructions)

（接線員指示）

Ted Tenthoff, Piper Sandler & Co.

Ted Tenthoff，Piper Sandler & Co.。

I didn't realize that there were openings at Karyopharm. I had to submit my resume as well, especially in the commercial group since that's going to be expanding. And that was kind of my follow-up question for -- what additional prep are you guys doing both from a drug supply side as well as what kind of additions need to be made to the commercial organization if EC hits and if we get on compendium or ultimately get approval in myelofibrosis, how does that change the organization?

我之前不知道 Karyopharm 還有職缺。我也得投一份履歷，尤其是商業團隊，因為那邊將會擴編。而這也算是我對——你們在後續的追問：無論是在藥品供應端你們正在做哪些額外準備，以及若 EC 取得成功、且我們被納入 compendium 或最終在骨髓纖維化獲得核准時，商業組織需要增補哪些人力？這會如何改變組織？

Yes, I'll start at a high level, Ted, great question. And I would love to talk, of course, if you're interested. But I'll turn to Sohanya for the later part. But overall, the organization is really well established and obviously, has been working over the last couple of years to make sure we leverage the strong capabilities we've built from a supply perspective, a very solid supply chain, very solid manufacturing here in the US and well ready to drive and support uptake for endometrial cancer and myelofibrosis as we continue to work to achieve labels and be able to commercialize in both those areas.

是的，Ted，我先從較高層次回答，這是個很好的問題。當然，如果你有興趣我也很樂意聊聊。不過後半段我會交給 Sohanya。整體而言，我們的組織已相當成熟，並且顯然在過去幾年持續努力，確保我們能善用在供應面所建立的強大能力：非常穩健的供應鏈、在美國本土非常扎實的製造能力，並已準備好推動並支持子宮內膜癌與骨髓纖維化的市場導入與使用成長；同時我們也持續努力取得適應症標示（labels），並能在這兩個領域進行商業化。

But I'll turn to Sohanya because meaningful work has been already in progress and meaningful opportunities as we move forward.

不過我會把問題交給Sohanya，因為有意義的工作已經在推進中，而且隨著我們往前走，也有很多有意義的機會。

Thanks, Richard. Yes, I'm very proud of the established team that we've set up, and there is a significant amount of prelaunch activities underway right now. So I'll break it down into two components. The global medical and scientific affairs obviously have been engaging strong with KOLs, strong presence at congresses, really understanding the treatment landscape and gathering those insights.

謝謝你，Richard。是的，我對我們建立起來的既有團隊感到非常自豪，而且目前正有大量的上市前活動在進行中。所以我會把它拆成兩個部分來說。全球醫學與科學事務團隊顯然一直在積極與KOL互動、在各大學術會議上有很強的能見度，真正去理解治療版圖並蒐集那些洞見。

From a commercial landscape, we've been extremely busy developing messaging, both promotional branded messaging, payer messaging, key account mapping, segmentation and so on. So lots of work going on. Again, as Richard mentioned, we have very strong capabilities. And then from a customer-facing model standpoint, there is very strong overlap at the key accounts and coverage in the key accounts. Specifically in myelofibrosis, it's a very concentrated group of accounts.

從商業面來看，我們一直非常忙於開發訊息，包括推廣用的品牌訊息、支付方訊息、關鍵客戶盤點與對應、分群等。所以有很多工作正在進行。同樣地，如Richard提到的，我們具備非常強的能力。另外，從面向客戶的模式來看，在關鍵客戶上有非常高的重疊度與覆蓋。特別是在骨髓纖維化（myelofibrosis）方面，這是一個高度集中的客戶群。

So we should be able to hit the ground running. In terms of endometrial cancer and the sales force coverage, again, strong coverage at key accounts, both in the academic and community medical oncology setting. In terms of the specialty gyn-oncs, there'll obviously be an incremental increase in sales coverage. But this is -- this specialty gyn-onc group really is also a very concentrated group of treating physicians. So we're very excited coming from a position of strength here and ready to have you join our team.

因此我們應該能夠迅速上手、立即展開。就子宮內膜癌以及銷售團隊覆蓋而言，同樣地，在關鍵客戶上有很強的覆蓋，涵蓋學術與社區的腫瘤內科場域。至於專科婦科腫瘤醫師（gyn-oncs），銷售覆蓋顯然會有增量提升。但這個專科婦科腫瘤醫師族群其實也是一個非常集中的治療醫師群。所以我們非常興奮，因為我們是站在優勢基礎上出發，也準備好歡迎你加入我們的團隊。

Michael King, Rodman & Renshaw.

Michael King，Rodman & Renshaw。

A couple of quick ones, if I may. Just wondering, the data that we'll see at ASCO, how closely is that going to map to -- I mean I always know the FDA gets a lot more data than what we see in public. But just as far as the data analysis and the timing is concerned, how much more will the -- will you take -- I guess the question, will you take another cut at the data before you present it to the FDA after investors and your peers see it at ASCO?

如果可以的話，我有幾個很快的問題。我想請問，我們在ASCO會看到的數據，會在多大程度上映射到——我的意思是，我一直知道FDA拿到的數據會比我們公開看到的多很多。但就數據分析與時程而言，在投資人與同業在ASCO看到之後、你們提交給FDA之前，你們會不會再對數據做一次分析（再切一次數據）？

Yes. Thanks for the question. So we're not commenting on the data that we're presenting to the FDA, right? In general, as I mentioned earlier, we'll provide greater clarity on our interactions with the FDA and next steps over the course of the next couple of quarters. I'm really excited about ASCO, right? I mean this is the first time the data are going to be presented by publicly.

會的。謝謝你的問題。所以我們不評論我們提交給FDA的數據內容，對吧？一般而言，如我先前提到的，我們會在接下來幾個季度中，對我們與FDA的互動以及後續步驟提供更清楚的說明。我對ASCO真的很興奮，對吧？我的意思是，這將是這些數據第一次公開發表。

I mean, obviously, really proud of the team for all the work that they've put into it, really excited to see Dr. Mascarenhas, one of the leading KOLs present these data on behalf of all the SENTRY investigators. And I think it's a great opportunity for people to really appreciate, right, sort of the benefit that selinexor in combination with ruxolitinib can provide to this population and the key differentiating aspects of this combination relative to other treatments that have been evaluated in myelofibrosis and certainly the current standards of care. So I hope you can be there live. I think it's going to be a great show.

我的意思是，我們當然為團隊投入的所有工作感到非常自豪，也很期待由Mascarenhas醫師——其中一位領先的KOL——代表所有SENTRY研究者來發表這些數據。我認為這是個很好的機會，讓大家真正理解，selinexor與ruxolitinib聯合用藥能為這個族群帶來的效益，以及相較於在骨髓纖維化中已被評估的其他治療、當然也包括目前的照護標準，這個組合的關鍵差異化之處。所以我希望你能到現場。我想這會是一場很精彩的發表。

I wouldn't miss it for all the money.

再多錢我也不會錯過。

That's awesome. That's great. That's great. But yes, I think it's going to be a really great opportunity, especially for the patients.

太棒了。很好。很好。不過是的，我認為這會是一個非常好的機會，尤其是對病人而言。

Well, to pick up on your comment about precedent, FDA is a precedent-driven organization and all the approved MF drugs have had some kind of a glitch in their data set. I mean, so you guys didn't hit SVR35, but you did hit VAF, you did hit survival. I just want to -- if you can just help us put it into context relative to approvals for things like pacritinib, momelotinib, et cetera.

延續你剛才提到的先例，FDA是一個以先例為導向的組織，而所有已核准的MF藥物在其數據集上多少都有一些瑕疵。我的意思是，你們沒有達到SVR35，但你們達到了VAF，也達到了存活。我只是想——如果你能幫我們把它放在脈絡中，對照像pacritinib、momelotinib等等的核准案例。

Sure. So we know that pacritinib and momelotinib, those are two great examples because while their focus also was on SVR and TSS, pacritinib clearly got an accelerated approval on SVR only, really important precedents because I think it highlights the FDA's appreciation and the importance of SVR as an important endpoint in myelofibrosis. In momelotinib, I think that example is also very relevant. Although those trials were also focused on SVR, TSS, those trials didn't necessarily show benefit as per their statistical analysis plan.

當然。所以我們知道pacritinib和momelotinib，這兩個是很好的例子，因為雖然它們的重點也放在SVR與TSS上，pacritinib很明確是僅憑SVR就獲得加速核准；這是非常重要的先例，因為我認為它凸顯了FDA對SVR作為骨髓纖維化重要終點的重視與認可。至於momelotinib，我認為那個例子也非常相關。雖然那些試驗同樣聚焦於SVR、TSS，但那些試驗未必依其統計分析計畫顯示出效益。

In this situation, the FDA definitely showed flexibility, I would say creativity, in identifying populations and other endpoints that clearly demonstrate that unmet need. So I provide those examples because it shows that this FDA is willing to look at the totality of the data, the data beyond just what's included as part of the primary endpoint. They're willing to look at other measures of clinical benefit and potentially provide a path forward for those meaningful treatments.

在這種情況下，FDA確實展現了彈性，我會說甚至是創意，去辨識特定族群與其他終點，清楚地證明存在未被滿足的需求。所以我提出這些例子，是因為它顯示這個FDA願意看整體數據證據（totality of the data），也就是不只看主要終點所涵蓋的內容。他們願意看其他臨床效益的衡量方式，並可能為那些有意義的治療提供一條前進的路徑。

And there are no further questions at this time. Mr. Richard Paulson, President and Chief Executive Officer, you may continue.

目前沒有其他問題。Richard Paulson先生，總裁兼執行長，您可以繼續。

Thank you, operator, and thank you again to everyone for joining us today and for your continued interest in Karyopharm. As you've heard, we are very encouraged by the progress we have made across our late-stage programs and remain very focused and disciplined in our execution through the next stage of important milestones.

謝謝接線員，也再次感謝各位今天加入我們，並持續關注Karyopharm。如各位所聽到的，我們對於在多個後期項目上所取得的進展感到非常振奮，並且在邁向下一階段的重要里程碑時，仍將非常專注且嚴謹地執行。

Most importantly, we remain committed to advancing selinexor's potential to bring meaningful new options to patients with both endometrial cancer or in the areas of endometrial cancer and myelofibrosis. And as we've heard, we look forward to seeing many of you at ASCO during our oral presentation of our SENTRY results. Thank you for joining us today.

最重要的是，我們仍致力於推進selinexor的潛力，為子宮內膜癌以及骨髓纖維化領域的病人帶來有意義的新選擇。也如各位所聽到的，我們期待在ASCO的SENTRY結果口頭報告中見到各位中的許多人。感謝各位今天加入我們。

Ladies and gentlemen, this does conclude your conference call for today. We thank you very much for your participation, and you may now disconnect. Have a great day, everyone.

各位女士、先生，今天的電話會議到此結束。非常感謝各位的參與，現在可以掛線。祝各位今天愉快。